Back to results

Effect of Oral Zinc Sulfate Supplementation on Enzymes of Urate Pathway

Primary Purpose

Infertility Unexplained

Status

Completed

Phase

Not Applicable

Locations

Iraq

Study Type

Interventional

Intervention

Zinc Sulfate

About this trial

This is an interventional treatment trial for Infertility Unexplained focused on measuring Uric acid, Adenosine deaminase, Zinc Sulfate, 5'-nucleotidase, Asthenospermia., Xanthine oxidase

Eligibility Criteria

26 Years - 36 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

The presence of asthenozoospermia in the semen sample.
Must be unable to reproduce.

Exclusion Criteria:

the absence of endocrinopathy, varicocele, and female factor infertility. Smokers and alcoholic men were excluded from the study because of their recognized high seminal ROS levels and decreased antioxidant levels.

Sites / Locations

Mahmoud Hussein Hadwan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Zinc sulfate

Healthy control

Arm Description

60 subfertile (age 32.5±3.23 year) men with asthenozoospermia was treated with zinc sulfate, every participant took two capsules of zinc sulfate per day for three months (each one 220 mg).

60 fertile (age 31.6±3.3 year) men, no treatment.

Outcomes

Primary Outcome Measures

Measurement the uric acid level in spermatozoa and seminal plasma by using spectrophotometer.

Clinical parameter

Secondary Outcome Measures

Measurement the adenosine deaminase activity in spermatozoa and seminal plasma by using spectrophotometer.

Enzyme

Measurement the xanthine oxidase activity in spermatozoa and seminal plasma by using spectrophotometer.

Enzyme

Measurement the 5'-nucleotidase activity in spermatozoa and seminal plasmaby using the spectrophotometer.

Enzyme

Full Information

NCT ID

NCT03361618

First Posted

November 7, 2017

Last Updated

December 4, 2017

Sponsor

Babylon University

Collaborators

Ministry of Health, Iraq

1. Study Identification

Unique Protocol Identification Number

NCT03361618

Brief Title

Effect of Oral Zinc Sulfate Supplementation on Enzymes of Urate Pathway

Official Title

Effect of Oral Zinc Sulfate Supplementation on Enzymes of Urate Pathway in Spermatozoa and Seminal Plasma of Iraqi Asthenospermic Patients

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Completed

Study Start Date

July 1, 2011 (Actual)

Primary Completion Date

June 1, 2012 (Actual)

Study Completion Date

June 1, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Babylon University

Collaborators

Ministry of Health, Iraq

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

Although many reports have investigated the relationship between subfertility and uric acid levels in semen, to the best of author knowledge, there is no study have been published to yet focus on the effects of asthenospermia treatments, such as given an oral zinc supplementation, on the activity of urate-related enzymes, which are important in fertility of human.

Detailed Description

The present study was designed to investigate the effect of zinc supplementation on the qualitative and quantitative characteristics of semen, along with uric acid levels and urate-related enzymes in the seminal plasma and spermatozoa of asthenospermic males.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Infertility Unexplained

Keywords

Uric acid, Adenosine deaminase, Zinc Sulfate, 5'-nucleotidase, Asthenospermia., Xanthine oxidase

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Semen volume after treatment.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Zinc sulfate

Arm Type

Experimental

Arm Description

60 subfertile (age 32.5±3.23 year) men with asthenozoospermia was treated with zinc sulfate, every participant took two capsules of zinc sulfate per day for three months (each one 220 mg).

Arm Title

Healthy control

Arm Type

No Intervention

Arm Description

60 fertile (age 31.6±3.3 year) men, no treatment.

Intervention Type

Dietary Supplement

Intervention Name(s)

Zinc Sulfate

Intervention Description

The subfertile group treated with zinc sulfate, every participant took two capsules of zinc sulfate per day for three months (each one 220 mg).

Primary Outcome Measure Information:

Title

Measurement the uric acid level in spermatozoa and seminal plasma by using spectrophotometer.

Description

Clinical parameter

Time Frame

up to three months.

Secondary Outcome Measure Information:

Title

Measurement the adenosine deaminase activity in spermatozoa and seminal plasma by using spectrophotometer.

Description

Enzyme

Time Frame

up to three months.

Title

Measurement the xanthine oxidase activity in spermatozoa and seminal plasma by using spectrophotometer.

Description

Enzyme

Time Frame

up to three months.

Title

Measurement the 5'-nucleotidase activity in spermatozoa and seminal plasmaby using the spectrophotometer.

Description

Enzyme

Time Frame

up to three months.

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

Male that undergo the presence of asthenozoospermia in the semen sample.

Minimum Age & Unit of Time

26 Years

Maximum Age & Unit of Time

36 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The presence of asthenozoospermia in the semen sample. Must be unable to reproduce. Exclusion Criteria: the absence of endocrinopathy, varicocele, and female factor infertility. Smokers and alcoholic men were excluded from the study because of their recognized high seminal ROS levels and decreased antioxidant levels.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Abdul Razzaq A. Alsalman, PhD

Organizational Affiliation

University of Babyblon

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Lamia A. Almashhedy, PhD

Organizational Affiliation

University of Babyblon

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Mahmoud Hussein Hadwan, PhD

Organizational Affiliation

University of Babyblon

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Abdulsamie H Alta'ee, PhD

Organizational Affiliation

University of Babyblon

Official's Role

Study Director

Facility Information:

Facility Name

Mahmoud Hussein Hadwan

City

Hilla

State/Province

Babylon

ZIP/Postal Code

51002

Country

Iraq

12. IPD Sharing Statement

Plan to Share IPD

Yes

Citations:

PubMed Identifier

31710193

Citation

Alsalman ARS, Almashhedy LA, Alta'ee AH, Hadwan MH. Effect of Zinc Supplementation on Urate Pathway Enzymes in Spermatozoa and Seminal Plasma of Iraqi Asthenozoospermic Patients: A Randomized Controlled Trial. Int J Fertil Steril. 2020 Jan;13(4):315-323. doi: 10.22074/ijfs.2020.5760. Epub 2019 Nov 11.

Results Reference

derived

Learn more about this trial

Effect of Oral Zinc Sulfate Supplementation on Enzymes of Urate Pathway

We'll reach out to this number within 24 hrs